Fluid control device

ABSTRACT

A fluid control device adapted to mix a fluid contained in a first medicinal vessel with a powder contained in a second vessel to produce therein a drug that is then delivered to a syringe for dispensing the drug. The device includes a fluid control member which in one operative position intercouples the first and second vessels to cause the fluid to mix with the powder to produce the drug in the second vessel. In another operative position of the control member, the second vessel is coupled to the syringe to deliver the drug thereto.

This application is a divisional of application(s) application number08/913,432 filed on Sep. 17, 1997, now U.S. Pat. No. 6,238,372 which isInternational Application PCT/US96/03732 filed on Mar. 19, 1996 andwhich designated the U.S., claims the benefit thereof and incorporatesthe same by reference.

FIELD OF THE INVENTION

The invention relates to fluid control devices in general and inparticular to fluid control devices adapted for facilitating the asepticadministration of drugs to patients.

BACKGROUND OF THE INVENTION

Drugs intended for parenteral administration are typically stored in amedicinal vessel either as a dry powder or as a solution. The solutioncan be ready for immediate use or in the form of a liquid concentratewhich requires reconstitution with a physiological solution prior toadministration in a similar manner to a dry powder drug. Thephysiological solution can be provided in a pre-filled syringe dr amedicinal vessel.

Medicinal vessels typically fall into one of three categories. The firsttype is a vial or a glass bottle closed by a rubber stopper which can bepenetrated by a puncturing tool, for example, a needle, and which isself-closing upon withdrawal of the puncturing tool. Such a vial orglass bottle can contain a single dose or a multiple dose of a drug. Thedrug contained in a vial can be under a high vacuum. The second type isan ampoule whose top portion is broken off enabling access to itscontents. The third type is an IV bag provided with a sample port forenabling access to its contents. The sample port can be of the pre-slitseptum type.

Regardless of the manner in which a drug is stored, there is a need totransfer fluid under sterile conditions before its administration to apatient by a dispensing tool be it a needle, a pre-slit septum, or thelike. When a prior dilution of a drug is required, the process requiresat least two fluid transfers. The problem of ensuring proper fluidtransfer under aseptic conditions is especially acute in the case ofself-administration of drugs by patients in their homes.

Assemblies which have hitherto been proposed for the asepticadministration of drugs are described in U.S. Pat. Nos: Des. 271,421,3,618,637, 3,757,981, 3,826,261, 3,957,052, 3,977,555, 3,993,063,4,051,852, 4,564,054, 4,604,093, 4,721,133, 4,758,235, 4,967,797,4,997,430, 5,201,705, 5,269,768, 5,279,576, 5,288,290, 5,334,163, and5,466,220, and European Publication Nos: 0 258 913 A2, 0 195 018 B1, 0192 661 B1, and 0 416 454 B1.

In particular, EP 0 521 460 B1 describes a fluid control device for usewith a syringe and a pair of medicinal vessels. The fluid control deviceincludes a housing with a Luer-connector port for receiving the syringeand second and third ports each comprising an adaptor having a fluidconduit member extending into the interior of a medicinal vessel whenattached thereto. In the housing, a flow control member is slidinglydisplaceable from a first flow control position enabling a flow pathbetween the two medicinal vessels when connected and a second flowcontrol position enabling a flow path between one of the medicinalvessels and the syringe.

SUMMARY OF THE INVENTION

The object of the invention is to provide fluid control devices enablingthe aseptic administration of drugs.

In accordance with the invention, there is provided a fluid controldevice for use with a syringe and at least one medicinal vessel, thefluid control device comprising:

(a) a first port;

(b) a second port for receiving the syringe;

(c) a third port comprising an adaptor having a fluid conduit memberextending into the interior of the medicinal vessel when attachedthereto; and

(d) a flow control member selectively disposable from a first flowcontrol position enabling a flow path between a first pair of two portsand a second flow control position enabling a flow path between a secondpair of two ports, said flow control member being coupled to one of saidports for manipulation between said flow control positions.

In accordance with the teachings of the present invention, there isprovided a family of fluid control devices which are adapted for theaseptic administration of drugs either directly or indirectly to apatient. The selection of the most suitable fluid control device dependson the type of drug to be administered to a patient, the manner in whichit is packaged, the manner in which it is to be administered to apatient and by whom apart from other factors. Some of the devices aredesigned to enable the reconstitution of a drug provided in a powderform or as a liquid concentrate. Some of the devices are suited forvials or ampoules containing a single dose of a drug whilst others aresuited for vials or IV bags containing multiple doses.

In a preferred embodiment of a fluid control device, the flow controlmember is rotatably mounted in a body member so as to be selectivelyrotatable between its first flow control position and its second flowcontrol position.

In a preferred embodiment of a fluid control device, the first port isadapted for dispensing a drug directly or indirectly to a patient and,as such, it can be provided with a needle, it can be fashioned as a maleLuer connector on which a needle can be mounted or it can be fashionedas a plastic cannula for insertion into a pre-slit septum. In such anembodiment, the adaptor is preferably coupled to a flow control memberadapted for rotation in a body member having the port adapted forreceiving a syringe and the dispensing port.

The adaptor can be integrally formed with the flow control member anddesigned so as to readily broken off therefrom after rotation of theflow control member from its first flow control position to its secondflow control position. Alternatively, the adaptor can be detachablyengaged to the flow control member by means of an interengaging meansenabling axial detachment of the adaptor from the body member on arelative rotation therebetween to a position which urges the flowcontrol member from its first flow control position to its second flowcontrol position.

In a preferred embodiment of a fluid control device suitable for usewith drugs which require reconstitution, the fluid control deviceincludes a fourth port in the form of an adaptor for enabling theattachment of a second medicinal vessel to the body member.

In a preferred embodiment of a fluid control device, the first port isalso provided with an adaptor adapted for attachment thereto of amedicinal vessel and, in this case, the port adapted for receiving thesyringe is rotatably coupled to the flow control member.

In each case, the adaptor can be adapted for attachment thereto of avial, an ampoule or an IV bag, the former requiring that the fluidconduit member be formed as a puncturing tool for piercing the vial'srubber stopper on its attachment thereto. In the case of attachment ofan ampoule, because the ampoule cannot be inverted, the fluid conduitmember is required to be provided as a long straw to enable all ornearly all of its contents to be aspirated therefrom.

The adaptor can also include a conduit for venting the vessel whenattached thereto. The conduit can include a filter for filtering the airtraversing therethrough. The filter can be deployed within a lateralcavity provided within the adaptor or, alternately, the filter can beprovided as a discrete element exterior to the fluid control device.

BRIEF DESCRIPTION OF THE DRAWINGS

For a better understanding of the present invention and to show how thesame may be carried out in practice, and solely by way of non-limitingexamples, reference will now be made to the accompanying drawings, inwhich:

FIG. 1 is a perspective view of an assembled fluid control deviceincluding a base member and an integrally formed adaptor cum flowcontrol member for use with a syringe and a medicinal vessel;

FIG. 2 is a perspective view of the fluid control device of FIG. 1before assembly;

FIG. 3 is a vertical cross sectional view of the fluid control device ofFIG. 1 along the line A—A after insertion of a syringe and theattachment of a vial and before rotation of the adaptor relative to thebase member;

FIG. 4 is a horizontal cross sectional view of the fluid control deviceof FIG. 1 along the line B—B after insertion of a syringe and theattachment of a vial and before rotation of the adaptor relative to thebase member;

FIG. 5 is a horizontal cross sectional view of the fluid control deviceof FIG. 1 along the line C—C before rotation of the adaptor relative tothe base member;

FIG. 6 is a vertical cross sectional view of the fluid control device ofFIG. 1 along the line A—A after rotation of the adaptor relative to thebase member;

FIG. 7 is a horizontal cross sectional view of the fluid control deviceof FIG. 1 along the line B—B after rotation of the adaptor relative tothe base member;

FIG. 8 is a horizontal cross sectional view of the fluid control deviceof FIG. 1 along the line C—C before rotation of the adaptor relative tothe base member;

FIG. 9 is a perspective view of a modified integrally formed adaptor cumflow control member adapted such that the adaptor breaks off from theflow control member on rotation of the adaptor relative to the basemember beyond a pre-determined position;

FIG. 10 is a perspective view of a fluid control device including themodified adaptor cum flow control member of FIG. 9 after the adaptor hasbeen broken off;

FIG. 11 is a perspective view of an assembled fluid control deviceincluding a base member and an adaptor designed for releasableengagement with the base member;

FIG. 12 is a perspective view of the fluid control device of FIG. 11after the adaptor has been rotated through a quarter turn ready for itsdetachment from the base member;

FIG. 13 is a vertical cross sectional view of the base member of thefluid control device of FIG. 11;

FIG. 14 is a vertical cross sectional view of the adaptor of the fluidcontrol device of FIG. 11;

FIG. 15 is a perspective view of the flow control member of the fluidcontrol device of FIG. 11;

FIGS. 16A and 16B are vertical cross sectional views of a fluid controldevice in which the flow control member is required to be rotatedthrough 180° to enable switching between its flow control position;

FIG. 17 is a vertical cross sectional view of a fluid control deviceprovided with an arrangement for the venting of a vial attached to itsadaptor;

FIGS. 18A and 18B are two views depicting a fluid control device havinga filter for filtering air venting a vial attached to its adaptor, thefilter being provided as a discrete element exterior to the device;

FIG. 19 is a vertical cross sectional view of a fluid control devicehaving an adaptor provided with a lateral cavity for receiving a filterfor filtering air venting a vial attached thereto;

FIG. 20 is a vertical cross-sectional view of a fluid control device ina first operative position enabling flow communication between amedicinal vessel containing a powder drug and a medicinal vesselcontaining a physiological solution for enabling reconstitution of thepowder drug;

FIG. 21 is a vertical cross sectional view of the fluid control deviceof FIG. 20 in a second operative position enabling flow communicationbetween the vial containing the reconstituted drug and a syringe;

FIG. 22 is a vertical cross sectional view of the fluid control deviceof FIG. 20 in a third operative position enabling flow communicationbetween the syringe and a dispensing port;

FIG. 23 is a longitudinal cross sectional view of a fluid control devicefor use with a syringe and a pair of medicinal vessels;

FIG. 24 is a horizontal cross sectional view of the flow control memberof the fluid control device of FIG. 23 along line D—D;

FIG. 25 shows a series of steps (FIGS. 25A-25F) depicting the operationof the fluid control device of FIG. 23;

FIG. 26 is a longitudinal cross sectional view of the fluid controldevice of FIG. 23 with a modified flow control member;

FIG. 27 is a horizontal cross sectional view of the flow control memberof FIG. 26 along line E-E in FIG. 26;

FIG. 28 is a longitudinal cross sectional view of a modified fluidcontrol device of FIG. 23 with an in-line filter; and

FIG. 29 is a longitudinal cross sectional view of a fluid control devicewith a modified adaptor enabling venting of a medicinal vessel attachedthereto fitted with a hydrophobic filter.

DETAILED DESCRIPTION OF THE DRAWINGS

FIGS. 1-8 depict a first embodiment of a fluid control device, generallydesignated 10, constructed and operative in accordance with theteachings of the present invention for enabling fluid flow controlbetween a syringe, a medicinal vessel and a dispensing port. The fluidcontrol device 10 includes an elongated base member 11 having a port 12adapted for receiving a syringe and a dispensing port 13 fashioned as aplastic cannula for insertion into a pre-slit septum assembly known inthe art per se. The port 12 is typically fashioned as a female Luerconnector.

As shown in FIG. 3, the port 12 includes a lumen 14 having an interioropening 14′ and the dispensing port 13 includes a lumen 16 having aninterior opening 16′. The lumens 14 and 16 are co-axial and in flowcommunication via a bore 17 transversely disposed relative to theelongated base member 11. The bore 17 includes an upper peripheralflange 18 and a lower minor peripheral abutment wall portion19′protruding radially inward relative to its major peripheral wallportion 19″ (see FIG. 5). As shown, the abutment wall portion 19′typically extends through an arc angle of about 90°.

The fluid control device 10 further includes an integrally formedadaptor cum flow control member, generally designated 20, for insertionthe bore 17 in which it is restrained therein by means of a peripherallyformed groove 22 designed for receiving the flange 18 therein. The flowcontrol member 20′ is formed with two flow ducts as follows: A firstflow duct 23 (see FIG. 3) in the form of an L-shaped channel having aradial aperture 23′ for registration with the interior opening 14′ andan axial aperture 23″ of a fluid conduit member 24 integrally formed aspart of the adaptor 20″ on disposition of the flow control member 20′ ina first flow control position, enabling flow communication between asyringe inserted in the port 12 and a vessel attached to the adaptor20″. A second flow duct 25 (see FIG. 4) in the form of a peripheralslightly longer than a semi-circular groove, having a first end portion25′ for registration with one of the interior openings 14′ and 16′ and asecond end portion 25″ for registration with the other of the interioropenings 14′ and 16′ on disposition of the flow control member 20′ in asecond flow control position, enabling flow communication between asyringe inserted in the port 12 and the dispensing port 13.

In addition, the flow control member 20′ is provided with a minorperipheral abutment wall portion 26′ protruding radially outwardrelative to its major peripheral wall portion 26″ (see FIG. 5). Asshown, the abutment wall portion 26′ typically extends through an arcangle of about 90°. The minor peripheral abutment wall portions 19′ and26′ are so disposed such that they assume substantially diagonallyopposing positions relative to one another (see FIG. 5) in the firstflow control position of the flow control member 20′.

The adaptor 20″ is shown to be adapted for the attachment thereto of avial 28 (not drawn to size) provided with a rubber stopper 29. As such,the fluid conduit member 24 is fashioned as a puncturing tool 30 forpenetrating a rubber stopper 29 on attachment of a vial 28 to itsadaptor 20″. Alternatively, the adaptor 20″ can be adapted for theattachment thereto of an ampoule 31 (not drawn to size), the differencebeing that such an adaptor will preferably have relatively long springygrips.

Each stage of the two stage operation of the fluid control device 10 forthe administration of a drug provided in powder form for dilution with aphysiological solution provided in a pre-filled syringe is now describedwith reference to FIGS. 3-5 and FIGS. 6-8, respectively.

As shown in FIGS. 3-5, the fluid control device 10 is best provided in aset-up position in which the flow control member 20′ is in its firstflow control position and the two minor abutment wall portions 19′ and26′ are diagonally opposed to one another. As shown, it should be notedas best seen in FIG. 4, that the semi-circular groove 25 registers withthe interior opening 16′ but does not provide a flow path.

In this arrangement, a pre-filled syringe 32 is inserted into the port12 and the vial 28 is attached to the adaptor 20″ by means of whichaction, the puncturing tool 30 punctures the vial's rubber stopper 29,thereby enabling flow communication with its interior via the fluidconduit member 24. Typically, the syringe 32 requires actuation forexpressing its contents into the vial 28 whilst, in some cases, if thecontents of the vial 28 are under vacuum, then the physiologicalsolution of the syringe 32 can be sucked into the vial without userintervention. Thereafter, the contents of the vial 28 are shaken so asto reconstitute the powdered drug. The fluid control device 10 togetherwith the vial 28 are then preferably inverted and the syringe 32 isaspirated so as to draw the reconstituted liquid drug thereinto.

Turning now to FIGS. 6-8, the vial 28 together with the adaptor 20″ arerotated in either a clockwise or a counter clockwise direction relativeto the base member 11 until such time that abutment wall portion 26′ isstopped by the abutment wall portion 19′ (see FIG. 8). On rotation ofthe adaptor 20″, the flow control member 20′ is rotated to its secondflow control position enabling a flow path between the syringe 32 andthe dispensing port 13 by means of the end portions 25′and 25′ of thesemi-circular groove 25 registering with the interior openings 14′ and16′. The drug can then be dispensed by actuation of the syringe 32.

It can now be readily appreciated that the fluid control device 10ensures that a drug can be administered to a patient under asepticconditions. Furthermore, it can be readily appreciated that the fluidcontrol device 10 presents a “fool-proof” delivery device in the sensethat a patient is required to perform a minimal number of actions toadminister a drug and that the drug can only be dispensed in a singleoperative position of the fluid control device.

FIGS. 9 and 10 depict a second embodiment of a fluid control device,generally designated 34, constructed and operative in accordance withthe teachings of the present invention for enabling fluid flow controlbetween a syringe, a medicinal vessel and a dispensing port. The fluidcontrol device 34 is similar in construction and operation to the fluidcontrol device 10 and therefore the same reference numbers are usedwhere appropriate.

The main difference between the two fluid control devices 34 and 10resides in the fact that the former includes an integrally formedadaptor cum flow control member 35 provided with a weakened portion,generally designated 36, between its abutment wall portion 26′ of itsflow control member 35′ and its adaptor 35″. As shown, this weakenedportion 36 is achieved by leaving radially extending vanes 36′ formed bycut-outs 36″.

The advantage of this design is that after rotation of the vial 28 (notshown) and the adaptor 35″ through 90° so as to rotate the flow controlmember 35′ from its first flow control position to its second flowcontrol position, any further torque applied will tend to snap off theadaptor 35″ which can then be discarded together with the vial, therebyrendering a less cumbersome and lighter remaining assembly so as tofacilitate the administration of a drug.

A further difference between the fluid control devices 34 and 10 residesin the fact that the former includes a dispensing port 38 fashioned as amale Luer connector.

FIGS. 11-15 depict a third embodiment of a fluid control device,generally designated 40, constructed and operative in accordance withthe teaching of the present invention for enabling fluid flow controlbetween a syringe, a medicinal vessel and a dispensing port. The fluidcontrol device 40 is similar in construction and operation to the fluidcontrol device 10 and therefore the same reference numerals are usedwhere appropriate.

The main difference between the two fluid control devices 40 and 10resides in the fact that the former includes an adaptor 41 designed fora non-destructive detachable engagement with a flow control member 42.As such, the base member 11 is provided with a downwardly dependingrectangular shaped skirt 43 provided with outwardly extending flanges43′ and 43″ for engagement by an upwardly extending rectangular shapedgrip 44 of the adaptor 41 provided with inwardly directed grooves 44′and 44″ for receiving the flanges 43′ and 43″. In addition, the adaptor41 is provided with an upwardly extending stem 46 provided with arectangular shaped key 46′ for insertion into a similarly sized andshaped slot 42′ formed in the underside of the flow control member 42.

In the fluid control device 40, the flow control member 42 is disposedin its first flow control position enabling a flow path between the port12 and a medicinal vessel to be attached to the adaptor 41 when theadaptor 41 is mounted on the base member 11. Conversely, on the rotationof the adaptor 41 relative to the base member 11 to a position enablingaxial detachment therefrom, the adaptor 41 urges the flow control member42 from its first flow control position to its second flow controlposition enabling a flow path between the port 12 and the dispensingport 13. Preferably, there is a screw thread engagement between the basemember 11 and the adaptor 41 designed such that there is an axialdisplacement of the adaptor 41 away from the base member 11 when it isrotated from its engaging position to its disengaging position.

It can be readily appreciated that the advantage of this design over thedesign of the fluid control device 34 whilst retaining all theadvantages of the latter resides in the fact that the former is reusableafter sterilization whilst the latter can only be used once due to thedestruction of the adaptor cum flow control member 35.

A further difference between the fluid control devices 40 and 10 residesin the fact that the former includes a dispensing port 13 provided witha needle 47.

FIGS. 16A and 16B depict a fourth embodiment of a fluid control device,generally designated 48, constructed and operative in accordance withthe teachings of the present invention for enabling fluid flow controlbetween a syringe, a medicinal vessel and a dispensing port. The fluidcontrol device 48 is similar in construction and operation to the fluidcontrol device 41 and therefore the same reference numerals are usedwhere appropriate.

The main difference between the two fluid control devices 48 and 41resides in the fact that the former includes a flow control member 49which is required to be rotated through a 180° turn between its firstflow control position (see FIG. 16A) and its second flow controlposition (see FIG. 16B). In particular, the flow control member 49includes an inclined channel 50 having a radial aperture 50′ forregistration with the interior opening 14′ and an axial aperture 50″ forregistration with the fluid conduit member 24 so as to enable the flowpath between a syringe and the interior of a medicinal vessel. And, theflow control member 49 includes a second inclined channel 52 having aradial aperture 52′ for registration with the interior opening 14′ and aradial aperture 52″ for registration with the interior opening 16′ so asto enable the flow path between a syringe to the dispensing port 13. Asshown, in this case, the lumens 14 and 16 are not co-axial.

FIGS. 17-19 depict other modified fluid control devices, generallydesignated 53, 54 and 55, constructed and operative in accordance withthe teachings of the present invention for enabling fluid flow controlbetween a syringe, a medicinal vessel and a dispensing port The fluidcontrol device 53, 54 and 55 are similar in construction and operationto the fluid control device 41 and therefore the same reference numeralsare used where appropriate. The main difference between the fluidcontrol devices 53, 54 and 55 and the fluid control device 41 is thatthey provide arrangements for venting a vial and, if necessary, forfiltering incoming air.

Turning now to FIG. 17, the fluid control device 53 includes an adaptor56 provided with a venting conduit 58 for venting a vial 28 to theatmosphere in addition to the fluid conduit member 24. The ventingconduit 58 is preferably provided with a filter 59 for filteringincoming air. Turning now to FIGS. 18a and 18 b, the fluid controldevice 54 is similar to the fluid control device 53 except that itincludes a filter 60 exterior to the adaptor 56. Turning now to FIG. 19,the fluid control device 55 is similar to the fluid control device 53except that its adaptor 61 includes an integrally formed laterallydisposed filter 62.

FIGS. 20-22 depict a fluid control device, generally designated 64, forenabling the reconstitution of a powder drug with a physiologicalsolution contained in a medicinal vessel instead of within a pre-filledsyringe as required with the fluid control device 10. The fluid controldevice 64 is similar in construction and operation to the fluid controldevice 41 and therefore the same reference numerals are used whereappropriate.

The main difference between the two fluid control devices 64 and 41resides in the fact that the former is adapted to be fitted with twomedicinal vessels and, as such, its base member His provided with a port12, a dispensing port 13 and two bores 17A and 17B which areinterconnected by a channel 65. As shown, the medicinal vessels arevials 28A and 28B where the vial 28A contains the powdered drug and thevial 28B contains the physiological solution for diluting the powdereddrug. As explained in greater detail hereinbelow for the case when thevial 28A has its contents under a high vacuum, the sequence and order ofthe attachment of the vials 28A and 28B to the adapters 41A and 41B isnot arbitrary.

In this case, the flow control member 42A has a first flow controlposition in which its L-shaped flow duct 23A registers in flowcommunication with the channel 65 and a medicinal vessel attached to itsadaptor 41A (see FIGS. 20 and 21) and a second flow control position inwhich its peripheral groove flow duct 25A registers in flowcommunication with the channel 65 and the dispensing port 13 (see FIG.22). In contrast, the flow control member 42B has a first flow controlposition in which its L-shaped flow duct 23B registers in flowcommunication with the channel 65 and a medicinal vessel attached to itsadaptor 41B (see FIG. 20) and a second flow control position in whichits peripheral groove flow duct 25B registers in flow communication withthe channel 65 and the port 12 (see FIGS. 21 and 22).

The operation of the fluid control device 64 for the administration of apowder drug provided in the pressurized vial 28A after reconstitutionwith a physiological solution provided in the vial 28B is now described.First, as shown in FIG. 20, the fluid control device 64 is provided inits first operative position, namely, enabling the flow path between thevials 28A and 28B when they are attached to the base member 11. Itshould be noted that the vial 28B is attached to the adaptor 41B andthereafter the pressurized vial 28A is attached to the adaptor 41A suchthat the physiological solution contents of the vial 41B is sucked intothe vial 28A. Reconstitution typically requires shaking the fluidcontrol device 64. As shown in FIG. 21, the adaptor 41B together withthe vial 28B are then rotated so as to enable their detachment from thebase member 11 whilst, at the same time, effecting the rotation of theflow control member 42B so as to enable a flow path between the port 12and the remaining vial 28 A. A syringe 66 is inserted into the port 12and, after inversion of the fluid control device 64 such that the vial28 containing the reconstituted drug assumes an upward position, thesyringe 66 is aspirated to draw the contents of the vial 28A thereinto.Thereafter, as shown in FIG. 22, the adaptor 41A together with the vial28A are rotated so as to enable their detachment from the base member 11while, at the same time, effecting the rotation of the flow controlmember 42A so as to enable a flow path between the syringe 66 and thedispensing port 13. Finally, in this position, the syringe 66 isactuated so as to express the drug for its administration to a patientvia the dispensing port 13.

FIGS. 23-25 depicts a fluid control device 67 allowing the preparationof a drug by the mixing between a first substance contained in a firstmedicinal vessel and a second substance contained in a second medicinalvessel and thereafter the transfer of the drug to a dispensing tool,namely, a syringe. The fluid control device 67 includes a base member 68having a generally tubular intermediate portion 70 defining a lumen 71in which a flow control member 72 is rotatably inserted. The flowcontrol member 72 has a port 73 for receiving a dispensing tool,typically, a syringe 74 (see FIG. 25). The port 73 is preferablyfashioned as a female Luer connector. The flow control member 72 alsohas integrally formed handles 76 for enabling a manual rotating thereof.As shown, a filter 77 can also be deployed within the port 73 forfiltering a drug on its aspiration into a syringe 74.

The base member 68 includes two adapters 78 and 79 which are adapted forthe attachment thereto of medicinal vessels. In this case, the adapters78 and 79 are adapted for the attachment thereto of vials and, as such,they include respective co-axial fluid conduit members 78′ and 79′fashioned as piercing tools for puncturing the vials'rubber stoppers.The fluid conduit members 78′ and 79′ have respective internal apertures78″ and 79″.

The flow control member 72 is rotatably mounted for enabling either, ina first flow control position, a flow path between vials attached to theadapters 78 and 79 or, in a second flow control position, a flow pathbetween a syringe and one of the vials. As such, in a similar manner tothe flow control member 20′ (see FIGS. 3 and 4), flow control member 72includes two flow ducts as follows: A first flow duct 80 in the form ofa peripheral groove slightly longer than semi-circular having endportions 80′ and 80″ for registration with the interior apertures 78″and 79″ so as to enable a flow path between the interiors of vials whenattached to the adapters 78 and 79; A second flow duct 82 in the form ofan L-shaped channel having a radial aperture 82′ for registration withthe interior opening 71′ and an axial outlet port 82′ so as to enable aflow path between a vial attached to one of the adapters 78 and 79 and asyringe inserted in the port 73.

The operation of the fluid control device 67 is now described withreference to the steps depicted in FIG. 25 for the case that a vial 83contains a dried drug, e.g. a powder, a crystalline material, alyophilizate, etc., stored under a high vacuum and a vial 84 contains aphysiological solution. As explained in greater detail hereinbelow forthe case when the vial 83 has its contents under a high vacuum, thesequence of attachment of the vials 83 and 84 to the adapters 78 and 79is not arbitrary.

The fluid control device 67 is typically provided in a hermeticallysealed package with its flow control member 72 set so as to enable theflow path between flow conduit members 78′ and 79′ by means of the ends80′ and 80″ of its semi-circular groove 80 registering with theirinterior openings 78″ and 79″ (FIG. 25A). The vial 84 containing thediluent solution is attached to the adaptor 78 (FIG. 25B), the action ofattachment puncturing its rubber stopper and thereafter the vial 83containing the dried drug is attached to the adaptor 79 (FIG. 25C)thereby sucking the diluent solution thereinto once its rubber stopperis punctured (FIG. 25D). The contents of the vial 83 are then shaken soas to mix the diluent solution with the dried drug.

The syringe 74 is inserted into the port 73 (FIG. 25D) and the flowcontrol member 72 is rotated through a quarter turn relative to the basemember 11 such that the flow path between the syringe 74 and the vial 83is enabled (FIG. 25E). The fluid control device 67 is then inverted(FIG. 25F) and the syringe 74 is aspirated so as to draw thereconstituted drug thereinto, the medicinal preparation passing througha deployed filter 77, if any, thereby becoming particle free foradministration to a patient.

FIGS. 26 and 27 depict the fluid control device 67 with a modified flowcontrol member 85 having just the L-shaped flow duct 82, therebyrequiring that it be rotated through a 180° turn for switching betweenits two flow control positions, the first flow control position beingbetween a syringe inserted in the port 73 and a first medicinal vesselwhilst the second flow control position being between a syringe insertedin the port 73 and a second medicinal vessel.

The difference between the flow control member 85 and 72 being that afluid control device 67 fitted with the former can be employed withmedicinal vessels in which their contents are under a low vacuum or novacuum, thereby requiring user intervention to perform the mixing of thepowder drug with the physiological solution. In particular, the flowcontrol member 85 is suitable for use with a fluid control device 67having an adaptor suitable for connection to an IV bag such that onsetting the flow control member 85 in its first operative position, thesyringe 74 is aspirated so as to introduce a predetermined volume ofdiluent solution thereinto. Thereafter, on setting the flow controlmember 85 into its second operative position, the syringe 74 is actuatedso as to introduce the diluent solution into a second medicinal vesselcontaining the drug to be reconstituted. After mixing of the drug withthe diluent solution, the syringe 74 is aspirated a second time so as tointroduce the medicinal liquid thereinto at which time the syringe 74 isremoved for administration of the drug to a patient. In this fashion,such a fluid control device can be used a number of times with one ormore medicinal vessels.

FIG. 28 depicts a fluid control device 86 with a port 87 provided withan integral in-line filter 88, thereby obviating the need for a filter77. FIG. 29 depicts a fluid control device 89 with a modified adaptor 90having a vent conduit 91 for venting the vial attached thereto providedwith a hydrophobic filter 92 so as to prevent wastage of the mixed drugwhen the fluid control device 89 is manipulated into the position shownin FIG. 25F.

While the invention has been described with respect to a limited numberof embodiments, it will be appreciated that many variations,modifications and other applications of the invention may be made.

What is claimed is:
 1. A fluid control device, for intermixing asubstance contained in a first medicinal vessel with a substancecontained in a second medicinal vessel to produce a drug transferablefrom a second vessel to a dispensing tool, said device comprising: A. arotatable cylindrical flow control member having an axial portterminating in a connector adapted for direct connection to a dispensingtool which receives a drug, B. first and second adapters associated withsaid control member, said first adapter having a port to which a firstvessel is attachable, said second adapter having a port to which asecond vessel is attachable, and C. means to turn the flow controlmember to a first operative position in which the member acts to couplethe port of the first adapter to the port of the second adapter wherebya substance in a first vessel can then flow into a second vessel to mixwith a substance therein to produce a drug, and to thereafter assume asecond operative position in which the port of the second adapter iscoupled to the port of the control member whereby a drug produced in asecond vessel can be delivered to a dispensing tool, whereby thedispensing tool is connectable to the connector after a mixing actionproducing a drug has been completed.
 2. A device as set forth in claim1, in which the connector on the port of said flow control member isadapted for connection to a dispensing tool which is a syringe foraspirating a drug, and in which said connector is a Luer connector towhich the syringe may be directly attachable.
 3. A device as set forthin claim 1, in which said first adapter is adapted for connection to afirst vessel which is a vial containing a liquid and being provided witha rubber stopper.
 4. A device as set forth in claim 3, in which the portin the first adapter has a sharp end adapted to pierce the stopper whenthe vial is attached thereto.
 5. A device as set forth in claim 1, inwhich said first and second adapters of said fluid control device areeach formed by a cylindrical shell, and the port in said first adapterand the port in said second adapter are each formed by a tube coaxialwith the shell.
 6. A device as set forth in claim 5, in which the shellsof the adapters have the same diameter and are mounted on opposite sidesof said control member.